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Virtual Manufacturing - how to manage third party contract manufacturers
This Pharmaceutical training will describe strategies and tactics with concrete examples of how you can set up quality systems that will assure compliance and successful operations and will satisfy the agencies.
When you outsource your supply chain (raw material procurement, manufacture, packaging and labeling) to a third party, you may delegate responsibility for these activities to that company. However, you are still responsible for the operation and are accountable to the agency to assure that all activities are conducted according to regulations, procedures and policies. This presentation will describe strategies and tactics with concrete examples of how you can set up quality systems that will assure compliance and successful operations and will satisfy the agencies.
Areas Covered in the seminar:
- Your obligations for oversight of the contract manufacturer.
- What the FDA and EMEA expects of you.
- A Checklist of what not to do.
- Quality Agreements - your assurance of commitment.
- What does oversight mean in real terms.
- When to set up the relationship and how to do it.
- Understanding why outsourcing makes makes sense and when it does not.
- The real cost of outsourcing and how to manage it.
Who will benefit:
This webinar will provide valuable information on what the agencies expect of a virtual Pharma/biotech company when they outsource their supply chain activities to a third party. The employees who will benefit include:
- QA management
- Supply chain managers
- Project managers
- QA auditors
- Logistics managers
- Manufacturing managers
Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, Pharma and venture capital industry. It provides consulting services in supply chain development and management, quality systems development and implementation, clinical development and monitoring, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.
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